(66 days)
Trident Anchor is indicated for use in the following:
Shoulder: Rotator Cuff Repair, Biceps Tenodesis
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament
Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;
Joint Capsule Closure
Elbow: Biceps Tendon Reattachment
The Trident Anchor System includes the Trident Anchor, which will be
presented sterile, pre-mounted on an inserter shaft w/anvil with or
without a threader tab and suture. The System will be deployed with
the use of a reusable Deployment Gun. The Anchor could be provided
with a variety of #2 suture options.
The provided text is a 510(k) summary for the Trident Anchor, a medical device. This type of document is filed with the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device, thereby not requiring a Premarket Approval (PMA) application.
A 510(k) summary does not typically contain detailed information about specific acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth methodologies in the way you've outlined for an AI/ML device. Instead, it focuses on demonstrating equivalence through:
- Indications for Use: Showing similar intended applications.
- Technological Characteristics: Comparing design, materials, and operating principles.
- Performance Data: Presenting results from various tests (e.g., mechanical, biocompatibility, sterilization) to show the device performs as intended and is equivalent to the predicate, but not usually in the context of an AI/ML model's diagnostic accuracy.
Therefore, many of the specific questions you asked cannot be answered directly from the provided text, as they pertain to the validation of an AI/ML system, which is a different regulatory pathway.
Here's an attempt to extract what is available and explain why other information is not present:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Inferred from 510(k) context) | Reported Device Performance (as stated in the 510(k) summary) |
|---|---|
| Substantial Equivalence: To predicate devices regarding indications for use, technological characteristics, and safety and performance. | "Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices." |
| Biocompatibility: Device materials must be safe for human contact. | (Implied by "safety and performance testing" and comparison to predicate devices, but specific results are not detailed in this summary.) |
| Mechanical Performance: The anchor must meet specific physical and mechanical requirements (e.g., strength, fixation). | (Implied by "performance and safety testing" and comparison to predicate devices, but specific results are not detailed in this summary.) |
| Sterilization: The device must be provided sterile. | "The Trident Anchor System includes the Trident Anchor, which will be presented sterile..." |
Study Details (Based on the provided 510(k) summary)
-
Sample size used for the test set and the data provenance:
- Not Applicable / Not Provided: This 510(k) is for a physical medical device (bone anchor), not an AI/ML diagnostic system. The "test set" in the context of a 510(k) for a physical device refers to various engineering and biological tests (e.g., mechanical strength, biocompatibility, sterilization), not a dataset of medical images or patient records for algorithmic evaluation.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Provided: Ground truth, in the context of expert consensus on medical data, is not relevant for the regulatory submission of a physical bone anchor. Safety and performance are established through laboratory testing and predicate device comparison.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable / Not Provided: This relates to expert review of medical data for AI/ML validation, which is not part of this 510(k) submission.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable / Not Provided: MRMC studies are specific to evaluating diagnostic devices, particularly those involving human readers (e.g., radiologists) and potentially AI assistance. The Trident Anchor is a surgical implant.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable / Not Provided: This question is relevant for AI/ML algorithms. The Trident Anchor is a physical device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable / Not Provided: For a physical device like a bone anchor, "ground truth" would be established through engineering specifications, material properties, and in vitro/in vivo biomechanical testing, rather than expert consensus on diagnostic images or pathology.
-
The sample size for the training set:
- Not Applicable / Not Provided: There is no "training set" in the context of a 510(k) for a physical device. This refers to data used to train an AI/ML model.
-
How the ground truth for the training set was established:
- Not Applicable / Not Provided: See above; this is not relevant for a physical medical device submission.
Summary of what is available from the document:
- The device is called the "Trident Anchor."
- It's a "Fastener, Fixation, Nondegradable, Soft Tissue Smooth or threaded metallic bone fixation fastener."
- It's indicated for various orthopedic repairs in the shoulder, knee, and elbow (e.g., Rotator Cuff Repair, Ligament Repair).
- It is considered "substantially equivalent" to predicate devices (ROC EZ Fastener, Arthrex Pushlock Anchor, ArthroCare Opus Magnum Implant) based on indications for use, technological characteristics, and safety and performance testing.
- The device will be presented sterile and pre-mounted on an inserter.
The document does not contain the specific performance metrics, study designs, or data provenance relevant to an AI/ML device validation, as it is for a traditional surgical implant.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.